510(k) K964843

IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT by Beckman Instruments, Inc. — Product Code JZH

K964843 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT". The FDA issued a decision of Substantially Equivalent on March 6, 1997. The device falls under product code JZH (Factor B, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5320. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.